Downstream Process Development Scientist (Pilot Scale)

Position Overview :

We are seeking a highly skilled and experienced Downstream Process Development Scientist to join our bioprocess development team, focusing on the pilot scale.

The successful candidate will play a key role in the development, scale-up, and optimization of downstream purification processes for fermentation (e.

coli, microbial, yeast). The ideal candidate will have hands-on experience in key downstream processing techniques such as Tangential Flow Filtration (TFF), centrifugation, and preferably spray drying.

This role will involve translating bench-scale processes to pilot-scale operations while working closely with upstream development, analytical, and manufacturing teams to ensure successful process transfers and scalability.

The position will have predominant focus on Downstream and occasionally work on upstream (training will be provided as needed)

Key Responsibilities :

• Pilot Scale Process Development : Lead and support the scale-up of downstream purification processes from bench scale to pilot scale, ensuring robust and reproducible purification of fermentation processes.
• Filtration & Separation : Optimize Tangential Flow Filtration (TFF), ultrafiltration / diafiltration (UF / DF), and microfiltration techniques at pilot scale for the concentration, purification, and clarification
• Centrifugation : Design and implement scalable centrifugation processes for the removal of cell debris, insoluble materials, and other contaminants in pilot-scale operations.
• Spray Drying (Preferred) : Develop and scale-up spray drying processes for transforming biologic solutions into dry powder forms.

Optimize parameters to achieve high yield, consistency, and stability at pilot scale.

• Scale-Up Support : Work closely with process engineers to ensure successful pilot-to-commercial scale-up, ensuring that processes are adaptable to larger manufacturing scales while maintaining product quality and consistency.
• Process Characterization : Perform characterization of critical process parameters (CPPs) and key performance indicators (KPIs) for downstream unit operations, including process robustness and scalability.
• Tech Transfer : Facilitate the transfer of pilot-scale processes to GMP manufacturing facilities, ensuring that all aspects of the process are documented, reproducible, and in compliance with regulatory requirements.
• Troubleshooting & Process Improvement : Identify and resolve process challenges encountered during pilot-scale operations.

Implement continuous improvement initiatives to enhance process efficiency, yield, and cost-effectiveness.

Documentation & Compliance : Write and review technical reports, standard operating procedures (SOPs), and process development documentation.

Ensure compliance with internal quality standards and regulatory requirements.

• Cross-Functional Collaboration : Work closely with upstream development, analytical development, quality control, and manufacturing teams to integrate downstream processes into overall bioproduction workflows.
• Innovation & Continuous Learning : Stay abreast of the latest advancements in downstream processing technologies and contribute innovative ideas to optimize existing processes and implement new techniques.

Qualifications :

• Demonstrated hands-on experience with Tangential Flow Filtration (TFF) and centrifugation at pilot scale.
• Experience with spray drying at pilot scale is highly preferred, or a strong willingness to develop expertise in this area.
• Strong knowledge of downstream process development, scale-up, and optimization principles.
• Strong analytical and problem-solving skills, with the ability to troubleshoot and optimize processes at scale.
• Experience in process characterization, process transfer, and GMP compliance.
• Excellent communication and collaboration skills to work effectively in cross-functional teams.
• Experience with pilot-to-commercial scale tech transfers.
• Knowledge of regulatory requirements and guidelines related to downstream processing for biologics.
• Experience working in GMP environments or supporting GMP operations (preferred)
7 days ago